This invention relates to therapeutic infusion assemblies and, more specifically, to a device for subcutaneous delivery of a fluid to a patient. The present invention provides an infusion set having a pivoting fluid connector and a base assembly having a base unit and a molded septum. The invention is easy to manufacture and assemble and is simple to use.
Prior art infusion sets provide a number of ways for engaging a fluid connector to a base. The base typically has a vertical cannula depending downward from a flat bottom. The fluid connector typically has a fluid line carrying fluid from a remote reservoir to the base. The fluid connector is typically adapted to being removed from the base of the infusion assembly so that one may have freedom of movement, by disconnecting the fluid connector and leaving only the base attached to the patient.
Many prior art infusion assemblies use septums, piercable with a needle. The septums perform one or more functions. For example, prior art infusion assemblies use a septum with a hollow needle for repeatedly piercing the septum. The piercing needle is normally a part of the fluid connector and adapted for delivery of a fluid from a remote reservoir through the needle to the patient. The base assembly usually includes a cannula which will receive the fluid and introduce it into the patient. The prior art shows that the septums also receive an insertion needle for initially affixing the infusion assembly to the patient.
One of the typical functions of a septum is to releasably seal a chamber, usually within a base assembly, when a needle is urged through it and subsequently removed. A septum may be disk shaped or tabular shaped and defines a wall that seals or separates two cavities. It is typically soft enough to be pierced repeatedly by a needle and reform its shape when the needle is removed. It may or may not include a self sealing slit. Further, the walls of the septum are typically under some compression such that when a needle is removed, resiliency will allow the septum to reform its integrity and maintain the seal between two cavities.
In a preferred embodiment of the present invention, a base assembly includes a septum. The base assembly has a cannula, and the cannula has a lumen axis. A septum in the base assembly aligned with the lumen axis is provided so that the insertion needle may be used to pierce the septum, passing through the cannula and setting the infusion assembly onto the patient. In the septum, vertical and horizontal channels are typically provided. The vertical channel is generally vertical with respect to the flat bottom of the base and the horizontal channel is horizontal with respect to the base. The vertical and horizontal channels are in fluid communication. The junction of the two channels is below that section of the septum intended for receiving the insertion needle.
Also provided is a novel fluid connector for pivotal engagement with the base assembly. The fluid connector has a fluid channel therein. The base assembly and the fluid connector are adapted such that the fluid connector may move from a first (non-operational) position to a second position (operational). The operational position provides fluid engagement with the horizontal channel of the base assembly to the fluid channel in the fluid connector. That is, the base assembly and the fluid connector are designed such that they pivotally engage to move the fluid connector from an operational position wherein the fluid channel therein is in axial alignment and in fluid communication with the horizontal channel of the base assembly (sometimes also referred to as a “use” or “down” position) to a non-operational position wherein the fluid channel of the fluid connector is parallel to the vertical channel of the base assembly and perpendicular to the horizontal channel of the base assembly (sometimes also referred to as the “nonuse” or “up” position).
Another feature of the present invention is a hinged leg having a foot section extending perpendicularly therefrom. The hinged leg may be part of the base assembly. In a first position biased upwardly and adjacent a fluid entry portal in the septum, the foot of the hinged leg blocks the entry portal to prevent material from entry or exit from the portal. In this blocking position, the fluid connector is not engaged with the septum and fluid is not communicating through the base assembly into the patient. When the fluid connector is engaged with the base assembly in operational positions, the hinged leg is urged downwardly and the foot is no longer blocking the entry portal. When the fluid connector is aligned in this arrangement fluid may be delivered through the infusion assembly and into the patient.